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NCT03112174 · OUTCOME

Steady-State PK of Venetoclax: AUC0-24 (Randomization Phase)

Study of Ibrutinib Combined With Venetoclax in Subjects With Mantle Cell Lymphoma (MCL) · Source last updated 2025-07-22

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
ng·h/mL
Interval / dispersion
Standard Deviation
Time frame
Week 6, Day 1: Predose, at Dose, 1 hour (± 15 minutes [min]), 2 hours (± 15 min), 4 hours (± 30 min), 6 hours (± 30 min), 8 hours (± 1 hour), 24 hours post-dose

What was measured

Pre-dose concentrations were applied as 24-hour concentrations in order to calculate steady-state PK parameters.

Analysis population: Participants receiving venetoclax with an evaluable PK assessment at given time point.

Groups in this outcome

Randomization Phase: Ibrutinb + Venetoclax

Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Randomization Phase: Ibrutinb + Venetoclax98

Reported measurements

Source class 1
Values in ng·h/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Randomization Phase: Ibrutinb + Venetoclax6500032900Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        32900
        value
        65000
denoms
  1. counts
    1. group Id
      OG000
      value
      98
    units
    Participants
description
Pre-dose concentrations were applied as 24-hour concentrations in order to calculate steady-state PK parameters.
dispersion Type
Standard Deviation
groups
  1. description
    Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
    id
    OG000
    title
    Randomization Phase: Ibrutinb + Venetoclax
param Type
MEAN
population Description
Participants receiving venetoclax with an evaluable PK assessment at given time point.
reporting Status
POSTED
time Frame
Week 6, Day 1: Predose, at Dose, 1 hour (± 15 minutes [min]), 2 hours (± 15 min), 4 hours (± 30 min), 6 hours (± 30 min), 8 hours (± 1 hour), 24 hours post-dose
title
Steady-State PK of Venetoclax: AUC0-24 (Randomization Phase)
type
SECONDARY
unit Of Measure
ng·h/mL

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice